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The drug, which filed for listing on June 30, is the second CAR-T therapy in the country to do so.
Ricky Lunsai Injection (tentative) (developed code: JWCAR029) is a CAR-T product developed by ThermoJono on the basis of JCAR017 in the United States, which was submitted to IND in December 2017 through Ming Polyseth for a clinical study on the treatment of relapsed lymphoma and leukemia, which was accepted in January 2018.
Insight database shows that the fastest-growing clinical treatment of recurring refractic B-cell non-Hodgkin's lymphoma is currently the fastest-growing clinical in China, and it is expected that the indications listed this time will be relapsed refractic B-cell non-Hodgkin's lymphoma.
addition, JWCAR029 for the treatment of primary drug resistance diffuse large B cell lymphoma is also in clinical phase 1, it is assumed that the adaptive disorder is intended to be included in the breakthrough therapy of the adaptation.
Photo Source: Insight Database () Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development, transformation and promotion of leading cellular immunotherapy, was founded in April 2016.
completed a $100 million round of Round B financing on June 9 this year, plus a total of more than $200 million raised.
is the first company in China to obtain IND clinical approvals for CAR-T cell (embedded antigen-treated T-cell) therapeutic products with CD19 as its target, leading THE CAR-T clinical research in China.
But on February 24, 2020, Fosun Kate's inlay antigen-treated T-cell (CAR-T) therapy Ikililunsai injection, introduced from Kite, was the first to submit a listing application, temporarily ahead of the drug Ming Juno.
at the 2019 ASH Conference, Drug Minerno announced the clinical efficacy of JWCAR029 for the treatment of R/R B-NHL.
study showed that for patients with poor prognostic R/R invasive B-NHL, infusion JWCAR029 provided good and lasting remission, with an ORR of 58.6% for all patients at 6 months, a CR rate of 55.2% ;D and an ORR of 45% for LBCL patients and a CR rate of 45%.
safety, JWCAR029-related adverse events are controllable, there are no CRS or NT-related deaths, and the 3/4 crS or NT rate is low, at approximately 6%.
two CAR-T products are currently on the market worldwide, both targeting CD19, Novart's Kymriah and Gilead's Kite's Yescarta.
The former is approved for second-line or above treatment in patients under 25 years of age with relapsed difficult-to-treat B-cell acute lymphoblastic leukemia (B-ALL) and adult patients with DLBCL, and the latter is approved for second-line treatment in two non-Hodgkin's lymphoma NHL, including DLBCL and the more rare primary diaphragm large B-cell lymphoma (PMBCL) adult patients.
, Yescarta has outperformed both CAR-T products in terms of post-market sales, with sales of $456 million in 2019, up 72.7% year-on-year.
's Kymriah has sales of $278 million in 2019.
yescarta's listing in China has helped to increase its competitiveness.
Table 1 Domestic and Foreign Target CD19 CAR-T Major Registered Clinical Trial Progress Statistical Date Ended: July 1 Original Title: Pharmaceutical Ming Juno CAR-T Product "Ricky Lunsey Injection" to be reviewed as a priority, new adaptations to breakthrough therapy!